Operator s manual. IMPORTANT: Please read this operator s manual carefully before using the BPro.

Transcription

1 HealthSTATS International Pte Ltd 3 Ang Mo Kio Stree 62 #08-25/26 LINK@AMK Singapore Phone: Fax: Heal hstats HealthSTATS Technologies (UK) Limited Gloucester Place, W1U 6JQ London. Phone: Fax: Enhancing life Be Pro active Operator s manual IMPORTANT: Please read this operator s manual carefully before using the ro. Authorized agent: R a di a l Pu l s e Wave Acq u i s i t i o n D e vi ce

2 ro Radial pulse wave acquisition device Operator s manual IMPORTANT: Please read this operator s manual carefully before using the ro.

3 HealthSTATS reserves the right to change the information in this manual without notice. No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of HealthSTATS International Pte Ltd. HealthSTATS may have patents or pending patent applications, trademarks, copyrights or other intellectual property rights covering the subject matter in this manual. The furnishing of this manual does not give anyone license to these patents, trademarks, copyrights or other intellectual property rights except specifically provided in any written license agreement with HealthSTATS International Pte Ltd. HealthSTATS assumes no responsibility or liability whatsoever for any incidental or consequential damages, or loss of anticipated benefits or profits, or loss or impairment of data arising from the use of this product. A-PULSE CASP, ro, rosoft and rosoftcasp are either registered trademarks or trademarks of HealthSTATS International in Singapore and other jurisdictions. Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or any other licensed healthcare practitioner HealthSTATS International Pte Ltd, Singapore. All rights reserved. Document no.: M6000J-EN-05 Released in July 2015 Printed in Singapore ii

4 Contents Introduction 1 Indications for use 2 Symbols 3 Precautions for use 4 Precautions 4 Points to note 4 Unpacking your ro package 6 Features and functions of the ro 7 Identifications of parts 7 Control buttons 8 Operating modes 9 Time/date mode 10 Time and date settings 10 Time and date setting sequence 10 AM mode 11 AM mode settings 11 AM mode parameters 12 Audible and visual alerts 12 Audible alerts 12 Visual alerts 13 Starting an AM session 14 Selecting the strap length 14 Taking calibration readings 14 Preparing the ro for calibration 15 Mounting the ro on the patient 16 Calibrating the ro 17 Verifying the calibration 17 Recalibrating the ro 18 Flowchart for starting an AM session 19 Things to note during an AM session 19 Information for the patient 20 Introduction 20 What is ambulatory blood pressure monitoring (AM)? 20 Precautions for using the ro 21 Removing the ro temporarily 22 Activity log 22 Terminating an AM session 24 After an AM session 25 Downloading AM data to a computer 25 Deleting AM data 26 iii

5 Contents Maintenance and servicing 27 Battery replacement 27 Strap removal 28 Strap installation 28 Cleaning the ro 29 Cleaning agent 28 Cleaning steps 28 Illustrations 28 Cleaning the strap 30 Servicing 30 Troubleshooting guide 31 Safety and accuracy of the ro 33 Electrical safety 33 Accuracy 33 Manufacturer s EMC declaration 34 Specifications 36 Option to select other devices 38 Residual risk evaluation 39 Replaceable component parts 40 Glossary 41 iv

6 Introduction The ro radial pulse wave acquisition device is based on arterial tonometry at the radial artery of the wrist. It can be used as part of the ro ambulatory blood pressure monitoring (AM) system, the A-PULSE CASP pulse wave analysis system, or the rosoftcasp 24-Hour Ambulatory /CASP Monitoring System. The ro AM system consists of the ro radial pulse wave acquisition device, a blood pressure () calibrator and the rosoft 24-hour AM application software. The ro is used to capture the pulse wave from the radial artery, and the calibrator is used to calibrate the ro before each AM session. Once calibrated, the ro is capable of recording up to 96 readings of systolic and diastolic blood pressure and pulse rate over a period of 24 hours. The rosoft software communicates with the ro to retrieve, analyze, display and print AM data. The A-PULSE CASP pulse wave analysis system consists of the ro radial pulse wave acquisition device, a calibrator and the A-PULSE CASP pulse wave application software. The ro is used to capture the pulse wave from the radial artery, and the calibrator is used to calibrate the pulse wave. Once the pulse wave is calibrated, the software is used to derive the central aortic systolic pressure, radial augmentation index (rai) and a range of other pulse wave indices. The software allows the pulse wave, blood pressure readings and pulse rate readings to be displayed, stored and printed. The rosoftcasp 24-Hour Ambulatory /CASP Monitoring System consists of the ro radial pulse wave acquisition device, a calibrator and the rosoftcasp 24-Hour Ambulatory /CASP application software. The ro is used to capture the pulse wave from the radial artery, and the calibrator is used to calibrate the pulse wave. Once the pulse wave is calibrated, the software is used to derive the central aortic systolic pressure, radial augmentation index (rai) and a range of other pulse wave indices. The software allows the pulse wave, blood pressure readings and pulse rate readings to be displayed, stored and printed. The MC3000 or MC3100 oscillometric blood pressure monitor, or an equivalent, may be used as the calibrator. This manual focuses on the ro radial pulse wave acquisition device. For information on the use of the rosoft, A-PULSE CASP and rosoftcasp 24-Hour Ambulatory /CASP application software, refer to their respective manuals. Introduction and indications for use 1

7 Intended Use and Indications for use The ro radial pulse wave acquisition device is intended for use with the calibrator and rosoft 24-hour AM application software to measure systolic pressure, diastolic pressure and pulse rate over a period of 24 hours. The ro radial pulse wave acquisition device is also intended for use with the calibrator and A-PULSE CASP pulse wave application software to derive the central aortic systolic pressure, radial augmentation index (rai) and a range of other indices from the radial pulse. The ro radial pulse wave acquisition device is also intended for use with the calibrator and rosoftcasp 24-Hour Ambulatory /CASP application software to manage 24-hour ambulatory blood pressure () and central aortic systolic pressure (CASP), and to retrieve, analyze, display and print AM report. For both applications, the ro is intended for use on patients who are eighteen (18) years or older, have a palpable radial pulse, and do not have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation. The results are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment. Introduction and indications for use 2

8 Symbols No. Symbol Description 1 This product complies with the European Council Directive 93/42/EEC (Medical Device Directive). 2 Type BF: Device (applied part) is designed to provide special protection against electrical shock 3 See accompanying documents or see instructions for use 4 Caution 5 Date of manufacture 6 Manufacturer 7 Authorized representative in the European Community 8 Dispose of this product and used batteries in accordance with the national regulations for the disposal of electrical products. 9 Prohibited action 10 Important information to note 11 Use by 12 Lot number 13 This product and its package do not contain natural rubber latex. 14 PN Part number 15 SN Serial number Symbols 3

9 Precautions for use Precautions DO read this operator s manual thoroughly before using the ro. For additional precautions refer to the calibrator instruction manual DO calibrate the ro before every AM session. DO keep the wrist still for about seconds during measurements for optimal results. DO try to keep a safe distance of 0.5 to 1 meter (1.6 to 3.3 ft) between the ro and sources of electromagnetic radiation such as microwave oven, television or mobile phones when measuring blood pressure. For more details, refer to the manufacturer s EMC declaration in this manual. DO NOT apply the ro to injured or irritated skin. DO NOT subject the ro to extreme temperatures, humidity or direct sunlight. DO NOT subject the ro to strong shocks, such as dropping it on the floor. DO NOT immerse the ro in water. The ro is mildly water-resistant (IPX2). Use a dry cloth to wipe the ro if it gets wet. DO NOT immerse the ro in cleaning solution. Follow the recommended cleaning instructions in this manual. DO NOT attempt to disassemble, service or repair the ro. Contact HealthSTATS or an authorized agent if a problem occurs. Follow the recommended instructions for replacement of the fastening strap. DO NOT use the ro with defibrillators. Remove the ro before using a defibrillator. DO NOT use the ro in the presence of electrosurgery. DO NOT use the ro for monitoring of blood pressure during exercise or any vigorous activity. DO NOT leave the ro in the Std by mode for an extended period of time so as to reduce battery power consumption. Switch back to the time/date mode when the ro is not in use. Points to note A qualified physician should be consulted for diagnosis and interpretation of the blood pressure patterns and other results obtained with the ro. The ro is suitable for use on adults with wrist circumference 13 cm. It is not suitable for use on children or patients with wrist circumference < 13 cm. Blood pressure measurements using the ro are based on calibration to the patient s unique pulse waveform. Calibration is required before every AM session. A person s blood pressure fluctuates over a 24-hour period and the ro will automatically measure blood pressure at regular preset intervals. Readings are stored in the memory of the ro and may be later downloaded to a computer using the rosoft software. For patients in shock, noninvasive methods of measuring blood pressure may not be reliable because of peripheral vascular changes. Invasive measurement should be considered for patients with signs of shock or whose blood pressure is unstable. Precautions for use 4

10 As with the manual auscultatory method, it is not always possible to obtain accurate noninvasive readings under certain conditions. Factors such as patient movement, incorrect positioning of the cuff relative to the heart level, extreme heart rates and arrhythmias can lead to inaccurate measurements. Vibrations, such as those in a moving vehicle, can also lead to inaccurate measurements. Excessive motion during a measurement cycle may affect the accuracy of the measurement. Three audible beeps are provided to alert the patient to a new measurement cycle and to remind the patient to keep the wrist still. An event code will be recorded by the ro whenever it is unable to provide valid blood pressure readings for a measurement cycle even after repeated attempts. The event code will appear on the AM report. Precautions for use 5

11 Unpacking your ro package Ensure that you have all the necessary items in your ro package. Refer to the components list provided separately. Unpacking your ro package 6

12 Features and functions of the ro Identification of parts LCD housing 9 C-bracket 2 Backlit LCD 10 Strap loop 3 button 11 Sensor housing 4 Communications port 12 Sensor plunger 5 Control button 13 Sensor positioning marker / Std by,, Mode/Set and 14 Sensor case cushion 6 Strap diverter 15 Connecting strap 7 Back case cushion 16 Sensor support strap 8 Fastening strap Features and functions of the ro 7

13 Control buttons Mode/Set Select operating mode Enter and exit setting mode Select and set parameter in setting mode Turn audible beep alerts ON or OFF (for AM session only) Illuminate backlight for 5 seconds /Std by Increase value Enter and exit calibration mode (Std by and ready) Select day or seconds for display Delete log Decrease value Display day of week and date (month and day) Calibrate ro Verify calibration and start AM session Terminate AM session button /Std by button Communications port Mode/Set button button button Features and functions of the ro 8

14 Operating modes Time/date mode Set time and date B P AM mode B P PC Conn mode Automatically take blood pressure measurements at preset intervals over a 24-hour AM session Store date and time stamp for every measurement Indicate optimum strap tension and pulsations for blood pressure measurement Calibrate ro before starting each AM session Enter systolic and diastolic calibration readings Delete AM data Download data to a computer that has rosoft blood pressure report management software installed B P Features and functions of the ro 9

15 Time/date mode Time and date settings This mode allows you to set and display time and date. 1. Press and hold /Std by to set the top row to display either seconds or the day of week. 2. Press to display the day of week and date (month and day) for 5 seconds. 3. Press and hold Mode/Set to enter the time/date parameter setting mode. The selected parameter will flash. 4. Press Mode/Set to select the parameter to be set. Press /Std by or to increase or decrease the value respectively. 5. Press and hold Mode/Set to exit the setting mode anytime. Press to turn the audible alerts* ON or OFF. Press and hold to illuminate backlight. Press and hold to switch between seconds and day. Press or press and hold to increase value. Press and hold to enter or exit the setting mode. Press to switch between parameters. Press to show month and day. Press or press and hold to decrease value. *The audible alerts apply to AM sessions only. Time and date setting sequence Time Seconds Minutes Day Month Year Hour Features and functions of the ro 10

16 AM mode AM mode settings This mode allows you to set or change parameter settings before performing an AM session. 1. Press the Mode/Set button to select the AM mode. Press to turn the audible alerts ON or OFF. Press and hold to illuminate backlight. AM mode screen without any data /Std by Press to change setting or delete log. Press or press and hold to increase value. Press and hold to enter or exit the calibration and verification mode. Mode/Set Press and hold to enter or exit the setting mode. Press to switch between parameters. Press to calibrate, verify and start AM session. Press to stop AM session. Press to change setting. Press or press and hold to decrease value. 2. Press and hold Mode/Set to enter the parameter setting mode. The parameters to be changed will flash. 3. Press /Std by to adjust the parameter upward, delete AM data, and enter the calibration and verification mode. 4. Press to adjust the parameter downward. 5. Press to calibrate, verify and start or stop a 24-h AM session. 6. Press to turn the audible alerts ON or OFF or to illuminate the backlight for 5 seconds. Features and functions of the ro 11

17 AM mode parameters Fixed parameters Interval Sampling duration Sampling rate Period On-demand parameters Log Delete Audible alerts The measurement interval is fixed at 15 minutes. This will yield 96 measurements over 24 hours. The sampling duration of the ro is fixed at 8 seconds. ro will sample 8 seconds worth of data and then select valid waveforms for calculation. The sampling rate of the ro is fixed at 60 points per second. The period for the AM session is fixed at 24 hours. The ro will automatically terminate the AM session after 24 hours. Denoted by Log del. After downloading the data, you can delete them from memory and get ready for the next AM session. Press /Std by to confirm the deletion and a completion message denoted by done will appear. Denoted by a bell icon ( ). When this is ON, the icon will be displayed on the ro. Audible and visual alerts Audible alerts It is recommended that the audible alerts ( ) be turned ON for all AM sessions. When this feature is ON, the audible alerts bell icon will be displayed and the ro will provide the following audible alerts during an AM session: Measurement begins Measurement repeats Measurement complete 3 short beeps during AM session just before the ro takes a blood pressure measurement. 1 long beep during AM session when the ro needs to re-take a blood pressure measurement. May occur up to two times. 1 short beep during AM session to indicate that the measurement is complete. The user has the option to turn the audible alerts ON or OFF at anytime in any mode. Features and functions of the ro 12

18 Visual alerts The ro provides a visual alert when the battery is low on power. Low battery When the low-battery symbol is displayed and flashing, the battery should be replaced. Refer to the section Battery replacement for more information on how to replace a battery. Features and functions of the ro 13

19 Starting an AM session Selecting the strap length 1. Before using the ro, measure the patient s wrist circumference using a tailor s measuring tape. 2. Select the strap length according to the table below: Wrist circumference Strap length cm 95 mm (3.7 in.), small cm 125 mm (4.9 in.), medium cm 155 mm ( 6.1 in.), large > 21.0 cm 185 mm (7.3 in.), extra large A strap that is too short or too long may not adequately secure the ro to the wrist. 3. Verify that the strap size is appropriate for the patient before using the ro. Taking calibration readings Step 1 Relax for at least 10 minutes and take 5 or more slow, deep breaths. Step 2 Take 4 measurements using the calibrator with the cuff wrapped around the arm on which the ro is mounted. Record the systolic, diastolic and pulse rate readings. Note: Ensure that the correct size is used. Allow an interval of 30 to 60 seconds between measurements. Refer to the instruction manual for the calibrator for details. Step 3 Discard the first set of readings. If any two of the remaining 3 readings for systolic or diastolic pressure differ by more than 10 mmhg, take more measurements until the last 3 consecutive readings for each pressure do not differ from each other by more than 10 mmhg. Then average the 3 readings for each pressure. Note: The average systolic and diastolic readings will be used for calibration. Step 4 Remove the cuff from the patient and turn off the calibrator. Starting an AM session 14

20 Preparing the ro for calibration Step 5 Ensure that the time and date on the ro are correctly set (refer to the section Time/date mode for details if necessary). Step 6 Select the AM mode. Press Mode/Set until the AM mode screen appears. Step 7 Enter the calibration setting mode. 2. Press /Std by to delete existing data. 1. Press and hold Mode/Set to enter the calibration setting mode. del will flash. B P B P Step 8 Input the average systolic reading into the ro. 1. Press Mode/Set. The systolic reading will flash 2. Press or press and hold /Std by or to set the systolic reading. Step 9 Input the average diastolic reading into the ro. 1. Press Mode/Set. The diastolic reading will flash B P 2. Press or press and hold /Std by or to set the diastolic reading. B P Starting an AM session 15

21 ro operator s manual Step 10 Confirm your calibration readings (e.g., 124/84). 1. Press and hold Mode/Set to exit the setting mode and to return to the APBM mode. 2. Press and hold /Std by to enter the Std by mode. B P Mounting the ro on the patient Step 11 Place your index, middle and ring fingers on the patient s wrist to palpate the radial artery. Note: The ro should be mounted on the wrist of the arm from which calibration readings were taken. Step 12 Locate the region where the radial pulse is most strongly felt, usually at the middle finger. Step 13 Position the sensor plunger over this region, using the white marks on both sides of the sensor housing as a guide. Note: Before mounting the ro, you may wish to apply Betnovate cream or a similar cream on the wrist area to minimize skin irritation during the AM session. Step 14 While holding the plunger in place, insert the strap through the diverter, pull on the strap and fasten the Velcro. The display will show Std by and then ready if the pulsations, as indicated on the pulse indicator, are acceptable. There should be at least 4 bar segments on the indicator. If necessary, re-position the plunger or adjust the strap tension until these two messages are displayed. Remind the patient to keep the wrist still. The ro should not be strapped too tightly to the wrist. Otherwise, it may obstruct blood circulation and cause numbness to the hand. If the patient complains of numbness, loosen the straps. Starting an AM session 16

22 Calibrating the ro Step 15 When the display shows ready with constant pulsations and at least 4 bar segments on the pulse indicator, press the button to calibrate the ro. Remember to keep the wrist still. This step will take about 12 seconds. Pulse indicator Press here Upon successful calibration, the calibration and pulse rate readings will be displayed. Verifying the calibration Step 16 To verify the calibration, press the button again within 2 minutes to activate a measurement. Remember to keep the wrist still. This step will take about 12 seconds. If the verification is successful, the pulse rate, systolic and diastolic readings will appear and the AM indicator (dot) will be displayed at top left corner of the LCD. The ro will start taking the measurements at the preset interval of 15 minutes for the next 24 hours. The indicator indicates that AM is in progress. AM indicator Press here B P B P Note: This verification must be completed within 2 minutes or otherwise CAL FAIL will be displayed and you will need to recalibrate the ro. Starting an AM session 17

23 Recalibrating the ro Step 17 Either of the following messages may appear on the ro during the verification: POS AdJ: This message could have resulted from wrist motion or improper sensor position during verification. Adjust the sensor position if necessary, keep the wrist still and then press the button again. CAL FAIL: This message appears possibly because the readings are NOT within ±10 mmhg of the calibration readings, which could have resulted from wrist motion or improper sensor position during verification. Adjust the sensor position if necessary and recalibrate the ro, as follows: Press Mode/Set until the AM mode screen appears. In AM mode, press and hold /Std by to enter the calibration mode. POS and Std by will appear. Repeat steps 15 and 16 to complete the recalibration. Press and hold /Std by to enter the calibration mode. Starting an AM session 18

24 Flowchart for starting an AM session Select AM mode Go to calibration setting mode Set systolic reading Set diastolic reading Return to AM mode Enter Std by mode Keep wrist still and wait for ready to display Put on ro Enter Std by mode Return to AM mode Press button to start calibration Keep wrist still for at least 12 seconds Calibration and pulse rate readings will be displayed upon successful calibration No Verification OK? Press button to verify the calibration ro successfully calibrated Yes Proceed with AM session Things to note during an AM session 1. The ro will automatically trigger measurements at the preset interval and give off 3 alarm beeps 3 seconds before starting each measurement. 2. Whenever possible, keep the wrist still during each measurement until the measurement is complete. 3. The ro will display the record number rec (3, 4, 5, 6 96) after each measurement. 4. If the ro is unable to obtain a valid blood pressure reading, it will produce a long beep and then activate a second measurement cycle. If this second attempt fails again, it will activate a third measurement cycle. 5. The ro has been programmed to repeat this 3-cycle sequence two more times, with an interval of one minute between sequences, if no valid readings are obtained. 6. If the ro is unable to obtain valid blood pressure readings after a 3-cycle sequence, it will display POS AdJ. You will have one minute to adjust the sensor position before the next measurement cycle is activated. An event code is stored if a measurement is unsuccessful or errors are detected. Starting an AM session 19

25 Information for patients Introduction This section is provided for the patient s use for ambulatory blood pressure monitoring applications. Your doctor has selected the ro ambulatory blood pressure monitor to measure your blood pressure for 24 hour period. The ro is a convenient way to record blood pressure that looks like and is applied like a wrist watch. ro allows you to continue with your normal activities while recording your blood pressure at regular time intervals. What is ambulatory blood pressure monitoring (AM)? Blood pressure is the force of the blood pushing against the walls of the arteries. Each time the heart beats it pumps blood into the arteries. Blood pressure is usually represented as S/D. Systolic blood pressure (S) is the pressure in your blood vessels when your heart contracts. Diastolic blood pressure (D) is the pressure in your blood vessels when your heart relaxes. Your blood pressure may rise and fall in a natural rhythm during the day and night. Ambulatory blood pressure monitoring (AM) refers to the collection of the overall pattern of your blood pressure over a 24-hour period. Knowledge of your blood pressure pattern helps your physician to better understand and support your overall health. The ro divides the day and night bands as follows Time (hrs) Duration Day band hours Night band hours The specified day and night bands are not user adjustable. Information for the patient 20

26 Precautions for using ro DO keep the wrist still for about seconds during measurements for optimal results. There will be 3 beeps to alert you just before a measurement cycle starts. Just relax, hold your wrist still, and breathe normally. DO try to keep a safe distance of 0.5 to 1 meter (1.6 to 3.3 ft) between the ro and sources of electromagnetic radiation such as microwave oven, television or mobile phones when measuring blood pressure. For more details, refer to the manufacturer s EMC declaration in this manual. DO NOT apply the ro to injured or irritated skin. Contact your physician if you experience any skin problem. DO NOT engage in any vigorous activity during the AM session. DO NOT subject the ro to extreme temperatures, humidity or direct sunlight. DO NOT immerse the ro in water. The ro is mildly water-resistant (IPX2). Use a dry cloth to wipe the ro if it gets wet. DO NOT set or reset the time or any AM settings during the monitoring period. Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or any other licensed healthcare practitioner. Information for the patient 21

27 Removing the ro temporarily It is recommended that you do not remove the ro during the 24-hour session, and to sponge your body clean instead of bathing or showering. However, if you have to remove the ro for any reason, please take care to strap it back in the original location. Please also note the removal and replacement in the activity log below. Activity log You are advised to keep a log of your activities during the AM session, such as the following: What medications you took and when you took them When you took your meals When you removed the ro from your wrist and when you strapped it back What physical or mental activities you were engaged in when measurements were being taken When you slept and when you woke up This log will help your physician interpret the AM data. You may use the log format shown on the next page. Information for the patient 22

28 Patient name/id number: Date Time Medication Activity/Comments Information for the patient 23

29 Terminating an AM session The AM indicator (dot) at top left corner of the LCD screen indicates that an AM session is progress. It will disappear once the session is completed or terminated. The AM session will stop automatically after 24 hours. To terminate an AM session before it is completed, you can simply remove the ro from the wrist and put it aside. The ro will continue to attempt to take measurements even though it has been removed. It will beep during these attempts but you can simply ignore the beeps. If you do not wish to be disturbed by the beeps, complete the steps below. Either way, the data that have already been captured will be retained by the ro. Step 1 Select the AM mode. The display will switch between the calibration readings and the time of calibration. AM indicator Pulse rate at time of calibration Date of calibration Press Mode/Set until the AM mode screen appears. Calibration readings Time of calibration Step 2 1. Press and hold Mode/Set. 2. Press and hold. The AM indicator at the top left corner will disappear and the AM session will be terminated. Step 3 Indicator has disappeared. Press and hold Mode/Set to return to the AM mode. Information for the patient 24

30 After an AM session Downloading AM data to a computer Step 1 Install the rosoft software on a computer. Refer to the rosoft user manual for detailed instructions. Step 2 Plug the USB connector of the ro USB data cable into a USB port of the computer. Step 3 Snap the cap at other end of the cable onto the ro, as follows: Lift up the latch Hold cap at a slight angle Align contact pins with COM port a) Lift up the latch on the cap of the ro USB data cable. Align the 3 contact pins with the communications port by holding the cap at a slight angle off the ro s face. b) Press the cap against the face of the ro. Ensure that the cap is flushed with the ro. c) Push down the latch to secure the cap to the ro. d) A click sound will be heard once the cap is latched properly. The latch will flush with the rim of the cap. Step 4 If necessary, activate or re-activate the ro. Refer to the rosoft user manual for detailed instructions. Step 5 Press the Mode/Set button to select PC Conn mode. After an AM session 25

31 Step 6 Start the rosoft software and click the Download icon. Step 7 Close the dialog box once the download is complete. Note: Refer to the rosoft user manual for complete instructions on downloading AM data to a computer, data analysis, data storage and report generation. Deleting AM data Complete the following sequence to delete all AM data: 1. Press Mode/Set to go to the AM mode. The calibration time and readings will flash alternately. 2. Press Mode/Set until Log del appears. B P 3. Press /Std by to delete AM data. 4. Press and hold Mode/Set to exit the setting mode and return to the AM mode. The AM data are now deleted and the ro is ready for the next AM session. After an AM session 26

32 Maintenance and servicing Battery replacement 1. Insert a coin of an appropriate size into the slot as shown. 2. Turn the battery cover with the coin in an anticlockwise direction until the cover pops out. 3. Remove the battery and insert a new one. Ensure that the positive polarity ( + sign) is facing up. 4. Put back the cover and using the coin, turn it in a clockwise direction until it locks. Note: Remember to reset the time after every battery change. 1. The ro will not operate properly if the battery is not properly installed. 2. Use only a CR V lithium coin-cell battery. Maintenance and servicing 27

33 Strap removal Spring bar removal tool Spring bar C-bracket Pointed end 1. Insert the pointed end of the strap changing tool into one of the C-bracket holes holding the spring bar. 2. Push in the tip of the tool and gently pull the strap away from the end of the C-bracket. Strap installation Fork 1. Insert one end of the spring bar diagonally into one of the C-bracket holes. 2. Insert the fork of the strap changing tool onto the top end groove of the spring bar and press it down. Slowly move the bar into position and then release the fork. A click sound will be heard if the spring bar locks into position with the hole of the C-bracket. Give the strap a gentle pull. If the spring bar does not dislodge, it means that the strap has been properly installed. Maintenance and servicing 28

34 Cleaning the ro The ro LCD housing and parts may be wiped with a clean, moist cloth to remove surface grime. It is recommended to clean the patient contact surfaces between use by different patients to maintain hygiene. The following method is recommended. Cleaning agents ASEPTI-zyme (ECOLAB Inc.) or equivalent enzymatic cleaner TRIAD medium alcohol prep pad (70% isopropyl alcohol pad or equivalent) Cleaning steps Clean and disinfect the ro patient contact surfaces including the back case cushion, straps, sensor case cushion, and plunger, as follows. 1. Wipe the surfaces thoroughly with a cotton wool moistened with ASEPTI-zyme cleaning solution. 2. Wipe the surfaces thoroughly with a clean cotton wool moistened with clean water to remove ASEPTI-zyme. 3. Disinfect and wipe the ro with an alcohol prep pad. Allow to air dry before use. Note: Do not allow moisture to enter the LCD or sensor housing during any of the above steps. Illustrations Cleaning the LCD housing and sensor housing 1. Wipe with clean cotton wool moistened with ASEPTI-zyme. 2. Wipe with clean cotton wool moistened with clean water to remove ASEPTI-zyme. 3. Disinfect with isopropyl alcohol prep pad and air dry. Maintenance and servicing 29

35 Cleaning the strap 1. Wipe with clean cotton wool moistened with ASEPTI-zyme. 2. Wipe with clean cotton wool moistened with clean water to remove ASEPTI-zyme. 3. Disinfect with isopropyl alcohol prep pad and air dry. Servicing The ro is not serviceable by the user. If you encounter any technical problem with the ro, please contact HealthSTATS or an authorized agent. The pressure sensor of the ro has to be tested every two years to ensure correct functioning and accuracy of the device. Contact HealthSTATS or an authorized agent for details. Maintenance and servicing 30

36 Troubleshooting guide Description Possible cause Corrective action No pulsation bar Full bar, non-pulsating Sensor not in ideal position to take readings. Signal over-saturation. You may have strapped the ro too tightly. a) Adjust the sensor so that the plunger rests on the spot with the strongest pulsations (refer to the section Mounting the ro on the patient ). b) If the problem persists, please contact HealthSTATS or an authorized agent. a) Loosen or re-strap your ro (refer to the section Mounting the ro on the patient ). b) Give the plunger a light tap to dislodge any particle that may have hindered its movement. c) If the problem persists, please contact HealthSTATS or an authorized agent. a) You may have moved your wrist while readings were being taken. b) Your ro may have shifted position since the last measurement. No existing historical records. Keep your wrist still during measurements. Re-adjust or restrap your ro (refer to the section Mounting the ro on the patient ). Records are available only when you have successfully calibrated your ro and taken readings. Troubleshooting guide 31

37 Low-battery level. Replace with new battery. Blank LCD Battery is flat. Replace with new battery. Troubleshooting guide 32

38 Safety and accuracy of the ro Electrical safety The ro has been tested to meet the electrical and electromagnetic safety requirements of the following standards: IEC Medical electrical equipment. General requirements for safety. IEC Medical electrical equipment. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems. IEC Medical electrical equipment. General requirements for safety. Collateral standard. Electromagnetic compatibility. Requirements and tests. Refer also to the section Manufacturer s EMC declaration. Accuracy The ro fulfills the provisions of the EC directive 93/42/EEC (Medical Device Directive) and conforms to the requirements of European and USFDA standards on noninvasive sphygmomanometers, in particular, the Requirements and test for non-automated measurement type and the Supplementary requirements for electromechanical blood pressure measuring systems. Refer to specifications for the standards. The ro has been clinically validated on subjects with the following blood pressure distribution: Systolic blood pressure Diastolic blood pressure Range Percentage of patients ANSI/AAMI/EN/ISO minimum requirements > 160 mmhg 16.9% 10% < 100 mmhg 10.1% 10% > 100 mmhg 12.4% 10% < 60 mmhg 10.1% 10% The arm circumferences of the subjects ranged from 20 to 48 cm (7.9 to 18.9 in.). The wrist circumferences ranged from 13 to 21 cm (5.1 to 8.3 in.). Safety and accuracy of the ro 33

39 Manufacturer s EMC declaration Manufacturer s declaration electromagnetic emissions The ro is intended for use in the electromagnetic environment specified below. The customer or the user of the ro should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment (guidance) RF emissions: CISPR 11 RF emissions: CISPR 11 Group 1 Class B The ro uses RF energy only for its internal functions. Therefore, RF emissions are very low and are not likely to cause any interference to nearby electronic equipment. The ro is suitable in all establishments, including domestic establishments and those directly connected to public low-voltage power supply network that supplies buildings used for domestic purposes. The ro is suitable for use with approved calibrators, the rosoft 24-hour AM application software, and approved accessories. It is not suitable for interconnection with other equipment. Manufacturer s declaration electromagnetic immunity The ro is intended for use in the electromagnetic environment specified below. The customer or the user of the ro should ensure that it is used in such an environment. Immunity test IEC test level Compliance level Electrostatic discharge (ESD): IEC Magnetic field power frequency: 50/60 Hz Magnetic field: IEC Conducted RF: IEC Radiated RF: IEC ±6 kv contact ±8 kv air ±6 kv ±8 kv Electromagnetic environment (guidance) Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 10 V RMS : 150 khz to 80 MHz 10 V/m for lifesupporting: 150 khz to 80 MHz inside ISM bands 10 V/m: 80 MHz to 2.5 GHz 10 V/m for lifesupporting Portable and mobile communications equipment should be used no closer to any part of the ro, including cables, than the recommended separation distance, d, calculated from the equation applicable to the frequency of the transmitter, as follows: 10 V d = (3.5/10) P meters 10 V/m d = (3.5/10) P meters for 80 MHz to 800 MHz d = (7/10) P meters for 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol: Manufacturer s EMC declaration 34

40 Manufacturer s declaration electromagnetic immunity NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ro is used exceeds the applicable RF compliance level above, the ro should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ro. b Over the frequency range of 150 khz to 80 MHz, field strengths should be less than 3 V/m. Manufacturer s EMC declaration 35

41 Specifications General Model T6200 series Display LCD, 20 x 15 mm, 2 lines Power source CR volt lithium coin-cell battery Battery life 1 to 6 months depending on usage Control buttons Mode/Set /Std by Display Ambulatory blood pressure monitoring (AM) mode Pulse wave analysis (PWA) mode Memory (for AM) Blood Pressure Measurement Measurement method Measurement site Calibration method Measurement time (for AM) Blood pressure range Pulse rate range Dimensions and Weight Watch head Sensor housing Weight Systolic pressure in mmhg Diastolic pressure in mmhg Pulse rate in beats/minute Pulsation bar 96 blocks of waveform Modified applanation tonometry Radial artery at the wrist (left or right) Oscillometric, performed before use 8 seconds per block of waveform 40 to 280 mmhg 30 to 180 beats/minute 44 [W] x 51 [L] x 19 [H] mm 32 [W] x 38 [L] x 16 [H] mm Approximately 50 grams with battery Others Operating conditions 10 to 40 C 15% to 90% relative humidity (noncondensing) 80 to 106 kpa atmospheric pressure Storage conditions -20 to 50 C 10% to 95% relative humidity (noncondensing) Fastening straps Fastening strap, 95 mm (3.7 in.), for wrist circumferences 130 to 150 mm (5.1 to 5.9 in.) Fastening strap, 125 mm (4.9 in.), for wrist circumferences 150 to 170 mm (5.9 to 6.7 in.) Fastening strap, 155 mm (6.1 in.), for wrist circumferences 170 to 210 mm (6.7 to 8.3 in.) Fastening strap, 185 mm (7.3 in.), for wrist circumferences 210 and larger (7.3 in. and Specifications 36

42 larger) Note: Straps not included in the components list can be purchased separately. Regulatory compliance Performance ANSI / AAMI / EN / ISO Safety IEC IEC IEC Environmental MIL-STD-810F (2000) IEC IEC IEC EN Note: The above specifications are subject to change without notice. *The ro may not meet its accuracy specifications if stored or operated outside the specified temperature and humidity ranges. Specifications 37

43 Option to select other similar devices Alternative devices similar to the ro are available in most markets. Users are advised to check the specifications of alternative devices. Option to select other similar devices 38

44 Residual risk evaluation Possible threat through residual risks Re-and/or cross infection; Inability to maintain hygiene safety Inadequate labeling; inadequate specification of pre-use checks Means to risk avoidance/reduction Patient contact surfaces can be disinfected. User instructions describe cleaning/disinfection. Device labeling lists pre-use check of device, calibrator, cuff, serial cable, and battery. Risk Acceptability acceptable acceptable Risks 39

45 Replaceable consumable components No. Part Description Part Number 1 Sensor Cushion P3604A 2 Leather fastening strap, 95 mm P3503A 3 Leather fastening strap,125 mm P3505A 4 Leather fastening strap,155 mm P3504A 5 Leather fastening strap,185 mm P3509A Replacements 40

46 Glossary Blood pressure () Diastolic pressure Systolic pressure Sometimes referred to as arterial blood pressure, is the pressure exerted by circulating blood upon the walls of blood vessels, and is one of the principal vital signs. It is the pressure that is exerted on the walls of the various arteries around the body in between heart beats when the heart is relaxed. It measures the amount of pressure that blood exerts on arteries and vessels while the heart is beating. Risks, Replacements and Glossary 41